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Macitentan/tadalafil - Actelion Pharmaceuticals

Drug Profile

Macitentan/tadalafil - Actelion Pharmaceuticals

Alternative Names: OPSYNVI; Tadalafil /Macitentan-Actelion

Latest Information Update: 27 Mar 2024

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At a glance

  • Originator Actelion Pharmaceuticals
  • Class Antifibrotics; Antihypertensives; Antineoplastics; Benzodioxoles; Bromobenzenes; Carbolines; Cardiovascular therapies; Erectile dysfunction therapies; Indoles; Pyrimidines; Skin disorder therapies; Small molecules; Sulfonamides
  • Mechanism of Action Endothelin A receptor antagonists; Endothelin B receptor antagonists; Type 5 cyclic nucleotide phosphodiesterase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Registered Pulmonary arterial hypertension
  • Phase III Pulmonary hypertension

Most Recent Events

  • 22 Mar 2024 Registered for Pulmonary arterial hypertension (In adults) in USA (PO)
  • 22 Mar 2024 Macitentan/tadalafil label has a boxed warning stating the risk of embryo-fetal toxicity
  • 25 Aug 2023 Efficacy and adverse event data from a phase III trial in Pulmonary arterial hypertension presented at the ESC Congress 2023 - Annual Congress of the European Society of Cardiology (ESC-Card-2023)
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